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The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy.
This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in China, and is designed to investigate the use of bendamustine in the treatment of Chinese participants with relapsed, rituximab-refractory indolent NHL. The study consists of a screening period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day cycles), and a long-term follow-up period for up to 2 years after the last dose of study drug. Participants are expected to participate in this study for approximately 2.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bendamustine | Experimental | Participants will receive bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine hydrochloride | Drug | Bendamustine will be be administered per dose and schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) (Assessed by Independent Review Committee [IRC]) | The ORR was defined as the percentage of participants who achieved a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on computed tomography (CT); spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. | From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) (Assessed by IRC) | Duration of response was defined as the time from the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first for participants with a best response of CR or PR determined by the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on CT; spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in SPD of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. Disease progression: any new lesion or increase by ≥50% of previously involved sites from nadir. |
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Inclusion Criteria:
- The participant has documented relapse from indolent B-cell NHL. Participants with the following subtypes of indolent NHL are eligible for this study: i) small lymphocytic lymphoma (peripheral B cell count <5000 cells/cubic millimeters [mm^3]) ii) lymphoplasmacytic lymphoma iii) splenic marginal zone B-cell lymphoma (±villous lymphocytes) iv) extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue type v) nodal marginal zone lymphoma (±monocytoid B-cells) vi) follicle center lymphoma vii) follicular (grade 1, 2, or 3a) lymphoma
- The participant has disease documented to have progressed despite rituximab treatment. The participant's disease is considered to be rituximab refractory if any of the following criteria are met at any time during the participant's treatment history (progression must be documented by computed tomography [CT] scan or magnetic resonance imaging [MRI] or biopsy) or if a participant has palpable lymph nodes that were well documented in size and, after rituximab treatment, palpable disease remains or comes back [CT, MRI, or biopsy is preferred and performed whenever possible to document progressive disease (PD)]: i) rituximab-only regimen: Participants who receive a full course of single-agent rituximab (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] weekly) and have no response (do not obtain a PR or better) to treatment or progress after a full regimen of rituximab was given.
ii) rituximab maintenance therapy or extended schedule: Participants who have a history of a full course of rituximab (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] as a single agent [weekly] or in combination with chemotherapy [day 1 of each of 4 cycles]) and are on a maintenance regimen, and progress before the next scheduled rituximab dose or after completing a maintenance rituximab regimen.
iii) rituximab-chemotherapy combination regimen: Participants who receive a full course of rituximab (at least 2 doses of 375 mg/m^2 or a therapeutically-active dose [on day 1 of each of 2 cycles]) in combination with chemotherapy and have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a regimen.
iv) full rituximab exposure treatment: Participants who have a history of a full course of rituximab treatment (at least 2 doses of 375 mg/m^2 [or a therapeutically-active dose] as a single agent or in combination with chemotherapy) and, in a subsequent rituximab/chemotherapy combination regimen, have no response (do not obtain a PR or better) to treatment or progress after the last dose of rituximab in a given regimen, even if the subsequent regimen included less than 2 doses of rituximab. Participants could receive additional systemic treatment after the qualifying rituximab regimen.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 001 | Beijing | 100021 | China | |||
| Teva Investigational Site 026 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33967195 | Derived | Shi YK, Hong XN, Yang JL, Xu W, Huang HQ, Xiao XB, Zhu J, Zhou DB, Han XH, Wu JQ, Zhang MZ, Jin J, Ke XY, Li W, Wu DP, Yang SM, Du X, Jia YQ, Liu AC, Liu DH, Shen ZX, Zhang LS, James L, Hellriegel E. Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study. Chin Med J (Engl). 2021 May 6;134(11):1299-1309. doi: 10.1097/CM9.0000000000001463. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bendamustine | Participants received bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
| Progression-Free Survival (Assessed by IRC) | Progression free survival was defined as the time from the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first for all participants. Disease progression/relapse: appearance of any new lesion or increase by ≥50% of previously involved sites from nadir. | From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
| Maximum Observed Plasma Concentration (Cmax) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Time to Reach Cmax (Tmax) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Rate Constant for Elimination (λz) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Percentage of the AUC0-∞ Based on Extrapolation (%AUCext) | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Half-Life (t½) of Bendamustine | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years) |
| World Health Organization (WHO) Performance Status | Number of participants with WHO performance status (improved, stayed the same, and deteriorated) at the end of treatment have been reported. | At the end of treatment (up to 2.5 years) |
| Number of Participants Who Need At Least 1 Hematologic Supportive Care (Plasma, Blood Cells, or Cytokines) | From first administration of bendamustine up to the end of treatment (up to 2.5 Years) |
| Number of Participants With Concomitant Medication Usage | Concomitant medications included all medications taken while the participant received study drug. | From first administration of bendamustine up to the end of treatment (up to 2.5 Years) |
| Beijing |
| 100029 |
| China |
| Teva Investigational Site 022 | Beijing | 100044 | China |
| Teva Investigational Site 004 | Beijing | 100071 | China |
| Teva Investigational Site 003 | Beijing | 100142 | China |
| Teva Investigational Site 002 | Beijing | 100191 | China |
| Teva Investigational Site 023 | Beijing | 100600 | China |
| Teva Investigational Site 016 | Beijing | 100730 | China |
| Teva Investigational Site 021 | Beijing | 110108 | China |
| Teva Investigational Site 015 | Changchun | 130000 | China |
| Teva Investigational Site 010 | Chengdu | 610041 | China |
| Teva Investigational Site 008 | Guangzhou | 510000 | China |
| Teva Investigational Site 007 | Guangzhou | 510060 | China |
| Teva Investigational Site 011 | Hangzhou | 310003 | China |
| Teva Investigational Site 019 | Harbin | 150081 | China |
| Teva Investigational Site 025 | Hefei | 230022 | China |
| Teva Investigational Site 024 | Lanzhou | 620102 | China |
| Teva Investigational Site 012 | Nanjing | 210000 | China |
| Teva Investigational Site 013 | Nanjing | 210029 | China |
| Teva Investigational Site 006 | Shanghai | 200032 | China |
| Teva Investigational Site 005 | Shanghai | 200035 | China |
| Teva Investigational Site 009 | Shenyang | 110001 | China |
| Teva Investigational Site 027 | Shenyang | 110042 | China |
| Teva Investigational Site 020 | Suzhou | 215000 | China |
| Teva Investigational Site 014 | Tianjin | 300041 | China |
| Teva Investigational Site 018 | Xi'an | 710032 | China |
| Teva Investigational Site 017 | Zhengzhou | 450000 | China |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The primary analysis set (PAS) included all enrolled participants who were treated with any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bendamustine | Participants received bendamustine hydrochloride administered at 120 mg/m^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) (Assessed by Independent Review Committee [IRC]) | The ORR was defined as the percentage of participants who achieved a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on computed tomography (CT); spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. | The primary analysis set (PAS) included all enrolled participants who were treated with any amount of study drug. | Posted | Number | percentage of participants | From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) (Assessed by IRC) | Duration of response was defined as the time from the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first for participants with a best response of CR or PR determined by the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on CT; spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in SPD of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. Disease progression: any new lesion or increase by ≥50% of previously involved sites from nadir. | The PAS included all enrolled participants who were treated with any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | months | From the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
| |||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (Assessed by IRC) | Progression free survival was defined as the time from the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first for all participants. Disease progression/relapse: appearance of any new lesion or increase by ≥50% of previously involved sites from nadir. | The PAS included all enrolled participants who were treated with any amount of study drug. | Posted | Median | 95% Confidence Interval | months | From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years) |
|
| ||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. | Posted | Mean | Standard Deviation | nanograms (ng)/milliliters (mL) | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Reach Cmax (Tmax) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. | Posted | Median | Full Range | hours | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. | Posted | Mean | Standard Deviation | ng*hour/mL | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ng*hour/mL | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Rate Constant for Elimination (λz) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1/hour | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of the AUC0-∞ Based on Extrapolation (%AUCext) | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percentage of AUC0-∞ | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Half-Life (t½) of Bendamustine | The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours | Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | Safety analysis set included all enrolled participants who were treated with any amount of study drug. | Posted | Count of Participants | Participants | From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years) |
|
| |||||||||||||||||||||||||||
| Secondary | World Health Organization (WHO) Performance Status | Number of participants with WHO performance status (improved, stayed the same, and deteriorated) at the end of treatment have been reported. | The PAS included all enrolled participants who were treated with any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At the end of treatment (up to 2.5 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants Who Need At Least 1 Hematologic Supportive Care (Plasma, Blood Cells, or Cytokines) | The PAS included all enrolled participants who were treated with any amount of study drug. | Posted | Count of Participants | Participants | From first administration of bendamustine up to the end of treatment (up to 2.5 Years) |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Concomitant Medication Usage | Concomitant medications included all medications taken while the participant received study drug. | Safety analysis set included all enrolled participants who were treated with any amount of study drug. | Posted | Count of Participants | Participants | From first administration of bendamustine up to the end of treatment (up to 2.5 Years) |
|
|
From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bendamustine | Participants received bendamustine hydrochloride administered at 120 mg/m^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles. | 30 | 102 | 99 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Infusion site phlebitis | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products R&D, Inc. | 1-888-483-8279 | USMedInfo@tevapharm.com |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
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